Diabetic KetoacidosisDKA-CogNCT02443415
Diabetic Ketoacidosis: Brain Morphology and Cognition
An observational study of Diabetic Ketoacidosis, run by Emory University at 2 sites in United States.
Trial summary
The purpose of this study is to assess brain and memory changes in patients with uncontrolled diabetes (a condition called diabetic ketoacidosis (DKA)) Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Ketoacidosis
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2015to 1 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects with diabetic ketoacidosis (DKA) will be recruited from Emory University Hospital and Grady Memorial Hospital patients when DKA is treated. Diabetic subjects and age-matched controls will be recruited from physician referrals.
Who may be able to join
- Type 1 or type 2 diabetes with diabetic ketoacidosis (DKA)
- Age 18-50 years
- Newly diagnosed or history of noncompliance with insulin therapy as precipitating cause of DKA
- No significant medical or surgical illness as precipitating cause of DKA
Who cannot join
- Significant medical/surgical illness as precipitating cause of DKA (i.e. myocardial infarction, major surgery)
- Associated significant medical or surgical condition within 6 months history
- History of hypoglycemia unawareness
- History of seizures, ischemic stroke or hemorrhage, and severe head trauma
- History of symptomatic stenosis of major intracranial vessels
- Dementia (mini-mental state examination (MMSE) score (r ≤ 24) or inability to cooperate)
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- Liver or renal failure or transplant
- Severe hypertension (systolic blood pressure (BP) >160 mm Hg and/or diastolic BP >100 mm Hg or subjects taking ≥ 2 antihypertensive medications)
- Malignancy
- Current recreational drug or alcohol abuse
- Magnetic resonance imaging (MRI) exclusions: any metal and bio-implants not compatible with 3 Tesla MRI, claustrophobia
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grady Health System
Atlanta, Georgia, 30303
Emory University School of Medicine
Atlanta, Georgia, 30322
About this study
Official title: Acute and Long-term Neuroanatomical and Cognitive Evaluation of Adult Patients With First and Recurrent Episodes of Diabetic Ketoacidosis
The purpose of this study is to assess brain and memory changes in patients with uncontrolled diabetes (a condition called diabetic ketoacidosis (DKA))
Read the detailed description
Diabetic ketoacidosis (DKA) is a common and serious medical problem. Most cases occur when patients forget or stop insulin injections. Some patients require frequent admissions to the hospital with DKA after stopping insulin. Many patients do not know why they stop insulin therapy. The investigators will test if patients with one or more episodes of DKA have poor memory and brain changes that may lead to poor management.
In this study, the investigators will perform memory testing and brain images in subjects with initial DKA episode and subjects with more than 3 episodes of DKA. The results will be compared to subjects with diabetes and no history of DKA and healthy (non-diabetic) subjects. Each subject with DKA will have an MRI and cognitive testing done shortly after hospital discharge, 1 month, and 3 months after hospital discharge. Diabetic subjects without DKA and healthy controls will only come in for a single baseline visit and have a MRI and cognitive testing done.
- Conditions
- Diabetic Ketoacidosis
- Medical subject headings
- Diabetic Ketoacidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Non-diabetic subjects | |
| Diabetics without DKA | Diabetic subjects (recent(< 1 year) diagnosis of diabetes) without a history of diabetic ketoacidosis (DKA) | |
| First episode of DKA | Diabetic subjects that just had their primary event of diabetic ketoacidosis (DKA) | |
| Three or more DKA episodes | Diabetic subjects who have had three or more diabetic ketoacidosis (DKA) episodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute change in brain morphology
Changes in brain morphology will include quantitative measurements of regional cortical volume as well as of hippocampal and thalamic volumes. Change is the difference from baseline MRI and 1 month MRI.
Measured: Baseline, 1 month
Secondary outcomes (3)
Long-term change in brain morphology
Changes in brain morphology will include quantitative measurements of regional cortical volume as well as of hippocampal and thalamic volumes. Change is the difference from baseline MRI and 4 month MRI.
Measured: Baseline, 4 months
Change in neurocognitive assessment
Assessment will focus in composite domains: verbal memory, visual memory, working memory, prospective memory, executive function processing speed, and reaction time. Change is the difference from baseline assessment and 3 month assessment.
Measured: Baseline (72 hours after DKA), 3 months
Change in neurocognitive assessment
Assessment will focus in composite domains: verbal memory, visual memory, working memory, prospective memory, executive function processing speed, and reaction time. Change is the difference from baseline assessment and 6 month assessment.
Measured: Baseline (72 hours after DKA), 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startFeb 2015
- Primary completion25 Oct 2016
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Umpierrez, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443415
- Sponsor's protocol ID
- IRB00077046
- Acronym
- DKA-Cog
- Status last verified
- Oct 2017
- First submitted
- 11 May 2015
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Long-term Neuroanatomical and Cognitive Evaluation of Adult Patients With First and Recurrent Episodes of Diabetic Ketoacidosis
- ClinicalTrials.gov ID
- NCT02443415
- Acronym / sponsor ID
- DKA-Cog / IRB00077046
- Conditions
- Diabetic Ketoacidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 25 Oct 2016 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess brain and memory changes in patients with uncontrolled diabetes (a condition called diabetic ketoacidosis (DKA))
Detailed description
Diabetic ketoacidosis (DKA) is a common and serious medical problem. Most cases occur when patients forget or stop insulin injections. Some patients require frequent admissions to the hospital with DKA after stopping insulin. Many patients do not know why they stop insulin therapy. The investigators will test if patients with one or more episodes of DKA have poor memory and brain changes that may lead to poor management.
In this study, the investigators will perform memory testing and brain images in subjects with initial DKA episode and subjects with more than 3 episodes of DKA. The results will be compared to subjects with diabetes and no history of DKA and healthy (non-diabetic) subjects. Each subject with DKA will have an MRI and cognitive testing done shortly after hospital discharge, 1 month, and 3 months after hospital discharge. Diabetic subjects without DKA and healthy controls will only come in for a single baseline visit and have a MRI and cognitive testing done.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | –Non-diabetic subjects |
| Diabetics without DKA | – | –Diabetic subjects (recent(< 1 year) diagnosis of diabetes) without a history of diabetic ketoacidosis (DKA) |
| First episode of DKA | – | –Diabetic subjects that just had their primary event of diabetic ketoacidosis (DKA) |
| Three or more DKA episodes | – | –Diabetic subjects who have had three or more diabetic ketoacidosis (DKA) episodes |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects with diabetic ketoacidosis (DKA) will be recruited from Emory University Hospital and Grady Memorial Hospital patients when DKA is treated. Diabetic subjects and age-matched controls will be recruited from physician referrals.
Key inclusion criteria (4 listed)
- Type 1 or type 2 diabetes with diabetic ketoacidosis (DKA)
- Age 18-50 years
- Newly diagnosed or history of noncompliance with insulin therapy as precipitating cause of DKA
- No significant medical or surgical illness as precipitating cause of DKA
Key exclusion criteria (11 listed)
- Significant medical/surgical illness as precipitating cause of DKA (i.e. myocardial infarction, major surgery)
- Associated significant medical or surgical condition within 6 months history
- History of hypoglycemia unawareness
- History of seizures, ischemic stroke or hemorrhage, and severe head trauma
- History of symptomatic stenosis of major intracranial vessels
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute change in brain morphology
Time frame: Baseline, 1 month
Changes in brain morphology will include quantitative measurements of regional cortical volume as well as of hippocampal and thalamic volumes. Change is the difference from baseline MRI and 1 month MRI.
3 secondary outcomes
Long-term change in brain morphology
Time frame: Baseline, 4 months
Change in neurocognitive assessment
Time frame: Baseline (72 hours after DKA), 3 months
Change in neurocognitive assessment
Time frame: Baseline (72 hours after DKA), 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Umpierrez, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Ketoacidosis, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute change in brain morphology (time frame: Baseline, 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.